Evaluating the Safety and Efficacy of Ondansetron in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Launched by TANTA UNIVERSITY · Mar 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ondansetron to see if it can help prevent a serious complication known as post-ERCP pancreatitis (PEP) after a procedure called endoscopic retrograde cholangiopancreatography (ERCP). ERCP is a common procedure used to diagnose and treat issues related to the pancreas and bile ducts, but it can sometimes lead to PEP, which can cause significant health problems. The trial is looking for participants who are at least 18 years old and have been recommended for an ERCP due to suspected problems with their pancreas or bile ducts, as long as their blood tests show normal levels before the procedure.

If you decide to participate, you will receive the usual care for your ERCP, and researchers will monitor your health to see if ondansetron helps prevent PEP. It's important to note that this study is not for everyone; for example, individuals with certain health conditions, such as uncontrolled diabetes or severe heart disease, or those who are pregnant or nursing, cannot participate. The trial is currently recruiting participants, so if you think you might qualify and are interested in learning more, it could be a valuable opportunity to contribute to important research while receiving care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age more than 18 years old.
• • 2. Gender: Males and Females
• • 3. Patients with suitable indications for ERCP due to suspected pancreato-biliary disorders.
• • 4. Blood amylase and lipase levels before ERCP are within the normal limits.
• Exclusion Criteria:
• • 1. Age of less than18 years.
• • 2. Uncontrolled diabetes mellitus (DM)
• • 3. Severe bleeding tendency
• • 4. Impaired renal function (serum creatinine \> 2 mg/dL), (creatinine clearance \<30 ml/min)
• • 5. Patients with severe heart disease.
• • 6. Subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct.
• • 7. Currently pregnant or nursing
• • 8. Admission due to established pancreatitis before ECRP
• • 9. Unwillingness to undergo ERCP.
• • 10. Previously documented allergy to ondansetron.